NCT03060915

Brief Summary

Those patient's that come to the sleep unit and that accept to participate in the study will undergo a polysomnography with the extra of an actigraphy placed in their no dominant arm wrist. The outcomes that will be analyzed are: Time in bed, assumed sleep time, wake time, sleep efficiency, sleep latency, light's on/light's off

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 10, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 23, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

April 1, 2019

Status Verified

March 1, 2019

Enrollment Period

1.5 years

First QC Date

February 10, 2017

Last Update Submit

March 29, 2019

Conditions

Obstructive Sleep Apnea

Keywords

ActigraphyPolysomnographyObstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

  • Sleep time (min)

    To compare the outcomes acquired with the actigraphy with those acquired by the Polysomnography

    3 months

Secondary Outcomes (3)

  • sleep efficiency

    3 months

  • Wake time

    3 months

  • sleep latency

    3 months

Study Arms (1)

Polysomnography and actigraphy

OTHER

Polysomnography and actigraphy

Device: PolysomnographyDevice: Actigraphy

Interventions

PolysomnographyDEVICE

Patient's undergo a polysomnography

Polysomnography and actigraphy
ActigraphyDEVICE

Patient's wear an actigraphy while doing the polysomnography

Polysomnography and actigraphy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient's with OSA suspicion undergoing a PSG in the sleep unit

You may not qualify if:

  • Neurologic disorders
  • Severe comorbidities
  • Other sleep disorders, such as insomnia
  • No informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clinic

Barcelona, 08036, Spain

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

PolysomnographyActigraphy

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

Monitoring, PhysiologicDiagnostic Techniques and ProceduresDiagnosisAccelerometryInvestigative Techniques

Study Officials

  • Josep Maria Montserrat, MD

    Hospital Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical doctor

Study Record Dates

First Submitted

February 10, 2017

First Posted

February 23, 2017

Study Start

September 1, 2016

Primary Completion

March 1, 2018

Study Completion

March 1, 2019

Last Updated

April 1, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)